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Food and Drug Administration (FDA) E-Signatures

ArentFox Schiff

E-signatures: When They’re Legal and Best Practices for Implementation

ArentFox Schiff on

With the widespread adoption of remote work, companies in all industries have turned to electronic signature (e-signature) solutions to sign the dotted line quickly and efficiently. E-signature solutions allow companies to...more

Verrill

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID...

Verrill on

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of...more

Hogan Lovells

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

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